YARLAP
FDA 510(k) clearance K141643 · decided 2015-04-24
Clearance details
- K-number
- K141643
- Device name
- YARLAP
- Applicant
- International Trade Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-19
- Decision date
- 2015-04-24
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- KPI
- Device class
- 2
- Regulation number
- 876.5320
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Oxford, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.